David Burke - IR, The Ruth Group Dave Gonyer - CEO Matt D’Onofrio - Chief Business Officer.

Analysts:.

Welcome to the Evoke Pharma Third Quarter 2015 Financial Results Conference Call. [Operator Instructions]. I would now like to turn the conference over to Mr. David Burke of The Ruth Group. Thank you, sir. You may now begin..

David Burke:.

Earlier today, Evoke issued a press release announcing financial results for the three and nine months ended September 30, 2015. We encourage everyone to read today’s press release as well as Evoke’s quarterly report on Form 10-Q which was filed with the SEC today.

The company’s quarterly report and press releases are available on Evoke’s website at www.evokepharma.com. In addition, this conference call is being webcast through the company’s web and will be archived there for future reference.

Please note that certain of the information discussed on the call today is covered under the Safe Harbor provisions of the Private Securities Litigation Reform Act. We caution listeners that during this call, Evoke management will be making forward-looking statements.

Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company’s business.

These forward-looking statements are qualified by the cautionary statements contained in Evoke’s press releases and SEC filings, including its annual report on Form 10-K and subsequent filings. This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, November 12, 2015.

Evoke undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call. With that, I would now like to turn the call over to Dave Gonyer.

Dave?.

Thank you, David. Thank you everyone who dialed in this afternoon for Evoke's third quarter 2015 earnings call. I will first provide a business overview of the company along with an update before I hand the call over to Matt to discuss the quarterly financials in greater detail, then we will open the line for question.

Let me first start off by saying that we remain extremely excited about the substantial market opportunity for EVK001 and believe we are taking all the appropriate steps to position ourselves for success when we submit our new drug application to the FDA for approval.

Throughout the quarter we achieved a number of significant accomplishments that support our enthusiasm as we look ahead. On the regulatory front our confidence has been bolstered by the FDAs recent draft guidance on gastroparesis as well as their agreement with our pediatric study plan that included a full waiver of pediatric trial.

Additionally on the clinical side the progress we have made in the enrollment of our Phase 3 EVK001 is very encouraging as we reached an important milestone at the end of the September with 150 patients enroll. Not only does this keep us on track with our expectations of completing enrollment during the first half of 2016.

It was also a milestone associated with our credit facility that we needed to achieve by November 1st. Financially we worked with Square 1 Bank to amend our credit facility to extend the interest only period to November 2016 and ended the quarter with $10.7 million in cash and cash equivalent.

These accomplishments coupled with prudent management of our asset market equity placement agreement with MLV strengthened our balance sheet and we believe provides us with capital to fund our business plan through October 2016.

So across the board and as a team the company remains well positioned and focused to achieve our near term goals over the next six to nine months. We continue to analyze commercial aspects of our product candidate in preparation for market introduction.

As I've been increasingly reported EVK001 targets a large population of gastroparesis patients that have been overlooked by big pharma until recently with Allergan and Glaxo studying drugs for this disease. Diabetes affects more than 29 million Americans and is the 7th leading cause of death in the U.S.

The number one known cause for gastroparesis is diabetes and diabetic gastroparesis a life threatening complication of diabetes worsens blood glucose control over the short term and may increase the risk of other diabetic complications longer term.

Given the increasing prevalence of diabetes, we expect a number of gastroparesis patients will grow as well underscoring the mounting interest in finding a reliable therapy for these patients. Currently oral metoclopramide is the only FDA approved outpatient product on the market indicated for the treatment of gastroparesis.

However it is well documented that patients suffering from gastroparesis are unable to predictably observe oral medication due to the symptoms of the disease.

We believe in our market research confirms that physicians and patient see a significant need for product like EVK001 which is not administered orally and could be done by patients themselves outside of a hospital setting.

Over the 35 years since the oral version of metoclopramide was approved there has been limited drug development for gastroparesis and several unfortunate development failures. We consequently believe that the unmet need for a non-oral treatment option is a significant and growing one.

Currently with no commercial marketing to physician or patients to raise awareness of gastroparesis there's still 4 million prescriptions written annually for the oral version of metoclopramide. We believe this is due to the lack of activity in the marketplace and an inadequate efficacy of the current treatment options.

We look forward to the opportunity to offer an oral outpatient alternative to physicians that need a more reliable solution to treat their patient and we believe marketing for this product can be done efficiently not to just capture current market share but to increase the potential market share by bringing greater awareness of gastroparesis to the public.

The frame back to the FDAs guidance for gastroparesis study that I mentioned earlier the FDA specifically state that patients with diabetic gastroparesis may have unpredictable gastric emptying and altered absorption of purely administered hypoglycemic drug.

This statement by the FDA is consistent with our belief that there is a need for a non-oral drug such as EVK001 to treat gastroparesis in diabetic As a formulation of medical mind [ph] that is delivered directly to the nose and into the bloodstream for the known absorption profile we believe and our previous trials have demonstrated that this delivery method may be more appropriate for these patients.

With EVK001 we’re working with the FDA approved molecule that is proven to be effective when absorbed into the patient system, that in concert with consistency of our trial design and endpoints with the FDAs draft guidance lead us to believe that there is reduce regulatory risk.

We're very pleased to be able to announce that 150 patients had been enrolled in the trial at the end of September and we remain optimistic that we will complete the trial enrollment during the first half of next year and with a four week trial and continuous cleaning of our database we anticipate some exciting milestones that we can announce in the coming months.

Before I hand the call over to Matt to discuss our financials in greater detail. Let me say that the company is operating from a position of strength not just clinically but financially as well. We believe that we have the cash, poor operation through October 2016.

This removes an overhang for the next 12 months so that we can focus an EVK001 and explore our options to bring it to market. With that I'll turn over to Matt to review the financials in more detail..

Thanks, Dave. So Dave briefly touched on a Evoke Parma achieved a significant milestone with enrollment of 75% of the trial which was a covenant associated with our credit facility with Square 1 Bank.

Given their confidence and support, Square 1 Bank also subsequently amended our loan and secured agreement with them to extend the interest only period term for an additional 12 months.

So now with a 24 month repayment period that starts in November of 2016 the company was able to decrease our debt payments about 2.2 million over the course of this next year.

When you combine the credit facility amendment with our aftermarket facility and prudent cash management we have 10.7 million on the balance sheet as of the end of the quarter, that's an 800,000 increase from the second quarter. So net-net our current cash position gives us an estimated runway through October of 2016.

As mentioned we have a lot of exciting activity that we expect to be able announce in the coming month. So let me reiterate on top what David just stated. We believe that Evoke Parma is well positioned financially to achieve our current goal. To give you a bit more specifics around the financials.

For the third quarter of 2015 net loss was approximately 2.7 million or $0.42 per share compared to a net loss of 3.8 million or $0.63 per share for the three month period ended September 30, 2014. The year-over-year decrease was primarily attributable to the timing of our trial enrollment and the through.

ECG or [indiscernible] trial that took place in the third quarter of 2014.. Research and development expenses totaled approximately 1.8 million for the three months ended September 30, 2015 compared to approximately 3.1 million for the three months ended September 30, 2014.

For the third quarter of 2015 general and administrative expenses were approximately 820,000 compared with approximately 733,000 for the third quarter of 2014.

And total operating expenses for the three months ended September 30, 2015 were approximately 2.7 million compared to a total operating expenses of approximately 3.8 million for the three months ended September 30, 2014. With that I'll turn over to the operator for questions..

[Operator Instructions]. Our first question comes from Difei Yang with Brean Capital. Please proceed with your question..

This Derrick filling in for Difei Yang.

The first question that I had was I know you gave an update in late September but can you give us additional updates on the enrollment progress of the EVK001?.

As I said really excited that in September to hit that 75% number, 150 patients enrolled. We’re continuing to enroll as we expected and that we’re still targeting the first half of 2016 to complete that enrollment so we’re on target for where we are or where we want to be at this time..

Okay.

Can you give any just like quantitative figures on how many patients you have so far?.

As I said at the end of the quarter we had 150 and we will complete the enrollment first half of next year. But as of right now we're not giving out the specific number..

Okay.

The other question was can you talk about your plan and provide some rough timelines if the readout of the Phase 3 study is positive?.

Sure. So as I said earlier the patient databases as we’re enrolling the study or cleaning the database as we go. So that and it's a four week trial so when the trial ends with last patient out, there will be a short timeline from that time of to get the top line data.

So we expect as we said if we finish enrollment in the first half we haven't given the specific dates as we said in the last conference call if you were on it, that enrollment waxes and wanes by month due to holidays and that sort of thing. So it's difficult to give a number out on a weekly basis or even on a monthly basis if you will.

So we expect the read out to be fairly soon after the last patient out..

[Operator Instructions]. Our next question comes from [indiscernible]. Please proceed with your question..

Just one quick one for me, has the rate of enrollment changed significantly from what you experienced in Q3 with some of these other trials in gastroparesis ramping up?.

No it's been the same..

[Operator Instructions]. Our next question comes from Paul Letty [ph], a Private Investor. Please proceed with your question..

I don't know if you want to comment on this or not but as an investor I watched the stock and I suppose you do to some degree but the average daily volume of the stock I got to guess was south of 50,000 but there are certain days when the stock trades enormous amounts of volume, I don’t know if that peaks your interest or not or do you’ve have comments on that or otherwise good luck with your endeavors..

I guess the only thing I can say is what we have seen over the last quarter the information that we have put out to the public has been well received at least in terms of creating additional trading interest.

That has overall taken me the daily volume and stocks up from roughly sort of 20,000 shares a day to maybe 80,000 on average but we have seen those spikes where it's been 2 million, 3 million even 4 million shares in a day traded. So I'd like to believe that it's in general commentary on an overall interest in the company and the stock trading..

Thank you. At this time I would like to hand the call back over to Mr. David Gonyer for closing comments..

Great. Thank you.

Let me just conclude by saying that we're in the homestretch to complete the Phase 3 study and prepare for the NDA filing and look forward to positioning EVK001 for the future where we believe there are a number of opportunities that we can pursue including potential parting opportunities or commercializing EVK001 on our own with a specialty sales force.

There has been no promotion in gastroparesis market which already has a base of 4 million prescriptions a year for oral metoclopramide and which likely only addresses a portion of the patients in need.

We remain focused on bringing non-oral in a much needed treatment option to a large targeted patient population and continue to build value for our shareholders. Thank you very much..

Thank you. This does conclude today's teleconference. You may disconnect your lines at this time and have a great day..